Frontier Pharma: Psoriasis - Identifying and

Commercializing First-in-Class Innovation

Published: May 2014

No. of Pages: 77

Frontier Pharma: Psoriasis - Identifying and Commercializing First-in-Class

Innovation
Summary
GBI Research has released the pharma report: Frontier Pharma: Psoriasis Identifying and Commercializing First-in-Class Innovation, which identifies and
assesses first-in-class innovation in the psoriasis development pipeline.
Over the last decade, a greater understanding of the underlying
pathophysiology of psoriasis has increased emphasis on developing
immuneomodulating therapies, as opposed to largely symptomatic treatments.
This is currently reflected in a competitive market dominated by multiple
disease-modifying biologic therapies (inhibitors of TNF-a and IL-12/IL-23) and
generic small-molecule therapies. Despite this, there are significant unmet
needs in the market, including safety concerns regarding immunomodulation.
This is a particularly important issue for the long-term commercial and clinical
success of psoriatic therapeutics, especially for emerging biologics. Another
unmet need is ease of drug application, as biologic drug delivery is invasive and
painful.
This allows for pipeline programs that offer a more refined approach to
immunomodulation and ease of drug application to gain market share upon
entry. In a pipeline of over 200 programs, approximately one third exhibits a
novel mechanism of action. Innovative programs target a wide range of
molecules implicated in immune signaling, such as cytokines and B and T cell
antigens. Several promising first-in-class therapies can selectively modulate
specific subsets of immune cells without compromising the entire immune
system.
In particular, biologics that target a subset of T cells, which are strongly
implicated in autoimmune pathophysiology, could allow for specificity of
immune suppression and thereby reduce adverse side effects. Based on clinical
trials, IL-17-targeted therapies have demonstrated superiority over currently
established therapies in achieving advanced clinical endpoints. Other agents
which activate regulatory arms of the immune system have also shown
promising clinical profiles. In addition, innovative programs that target
molecules have only recently gained recognition of their therapeutic value in the
treatment of psoriasis, including novel angiogenic proteins, signaling
transduction proteins and novel nuclear receptors. Despite their recent

implication in disease pathophysiology, many of these agents have also

demonstrated clinical utility in the treatment of psoriasis and are likely to
contribute to a diversified therapeutic landscape.
Scope
- A brief introduction to psoriasis, including symptoms, pathophysiology, and
overview of pharmacotherapy
- The changing molecular target landscape between market and pipeline and
particular focal points of innovation
- Overview of how innovative products are contributing to the pipeline and
market for psoriasis
- Comprehensive review of the pipeline for first-in-class therapies, analyzed on
the basis of phase distribution, molecule type, molecular target, and
administration route
- Identification and assessment of first-in-class molecular targets with a
particular focus on early-stage programs of which clinical utility has yet to be
evaluated, as well as literature reviews on novel molecular targets
- Assessment of the licensing and co-development deals for psoriasis therapies
Reasons to buy
- Understanding of the focal shifts in molecular targets in the psoriasis pipeline
- Understanding of the distribution of pipeline programs by phase of
development, molecule type and molecular target
- Scientific and clinical analysis of first-in-class developmental programs
- Assessment of the valuations of licensed and co-developed psoriasis
treatments
- A list of the first-in-class therapies potentially open to deal-making
opportunities.
- Analysis of financial valuations on licensed or co-developed first-in-class
therapies and generics

Detailed report at:

http://www.reportsandintelligence.com/frontier-pharma-psoriasisidentifying-and-commercializing-first-in-class-innovation-market

Table of Content
1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 6
2 The Case for Innovation 7
2.1 Growing Opportunities for Biologic Products 7
2.2 Diversification of Molecular Targets 7
2.3 Innovative First-in-Class Product Developments Remain Attractive 7
2.4 Changes in the Clinical and Commercial Environment Will be More
Favorable to Products That Target Niche Indications and Patient Populations 8
2.5 Innovation in Psoriasis 8
3 Clinical and Commercial Landscape 9
3.1 Disease Introduction 9
3.2 Epidemiology 9
3.3 Etiology 10
3.3.1 Genetic Predisposition 10
3.3.2 Environmental Factors 10
3.4 Pathophysiology 10
3.4.1 Keratinocytes 10
3.4.2 Dendritic Cells 11
3.4.3 T-Cells 11
3.4.4 Angiogenesis 11
3.4.5 Growth Factors 11
3.5 Symptoms and Co-morbidities 12
3.5.1 Skin Manifestations 12
3.5.2 Psoriatic Arthritis 12
3.5.3 Uveitis 12

3.5.4 Cardiovascular Disease 12

3.5.5 Psychological Impact 12
3.6 Diagnosis of Psoriasis 13
3.6.1 Diagnosis of Psoriatic Arthritis 13
3.7 Treatment 13
3.7.1 Pharmacological Therapies 13
3.7.2 Topical Medications 13
3.7.3 Systemic Medications 14
3.7.4 Non-Pharmacological Therapies 14
3.7.5 Combination and Rotational Therapies 15
3.8 Overview of Marketed Products for Psoriasis 16
3.8.1 Oral Non-Biologic DMARDs 16
3.8.2 Off-Label Non-Biologic DMARDs 19
3.8.3 Biologics 19
3.8.4 Comparative Efficacy and Safety of Marketed Products 23
3.8.5 Unmet Need 26
4 Assessment of Psoriasis Pipeline and Innovation 27
4.1 Overview 27
4.2 Comparative Efficacy and Safety of Pipeline Programs 29
4.3 Comparative Distribution of Programs in the Psoriasis Market and Pipeline
by Therapeutic Target Family 31
4.4 Comparative Distribution of Programs with First-in-Class and Established
Molecular Targets 33
4.5 Pipeline Programs Targeting Established Molecular Targets 36
4.6 First-in-Class Pipeline Programs with Novel Molecular Targets 38
5 First-in-Class Target and Pipeline Program Evaluation 40
5.1 Cytokines and Receptors 40
5.1.1 Pipeline Programs Targeting Tumor Necrosis Factor Receptors 40
5.1.2 Pipeline Programs Targeting Interleukin-6 42
5.1.3 Pipeline Programs Targeting Interleukin-8 43
5.1.4 Pipeline Programs Targeting Interleukin-17 44
5.1.5 Pipeline Programs Targeting Interferon-? 45
5.2 B and T Cell Antigens 46
5.2.1 Pipeline Programs Targeting Cluster of Differentiation 4 46
5.2.2 Pipeline Programs Targeting Cluster of Differentiation 28 47
5.3 Intracellular Kinases 48
5.3.1 Pipeline Programs Targeting Interleukin-1 Receptor-Associated Kinase-4
48
5.4 Nuclear Receptors 49
5.4.1 Pipeline Programs Targeting Retinoic Acid Receptor-Related Orphan

Receptor 49
5.5 Growth Factors 51
5.5.1 Pipeline Programs Targeting Transforming Growth Factor-? Receptor 51
5.5.2 Pipeline Programs Targeting Insulin Receptor Substrate 52
5.6 Ion Channels 53
5.6.1 Pipeline Programs Targeting Calcium Release-Activated Calcium Channel
53
5.7 Integrins 54
5.7.1 Pipeline Programs Targeting Vascular Adhesion Protein-1 54
5.8 Other 55
5.8.1 Pipeline Programs Targeting F1F0-Adenosine Triphosphate Synthase 55
5.8.2 Pipeline Programs Targeting Cathepsin S 56
5.9 Conclusion 57
6 Deals and Strategic Consolidations 59
6.1 Licensing Agreements 59
6.2 Major Co-development Deals 62
6.3 First-in-Class Developmental Programs Not Involved in Co-Development or
Licensing Deals 65
7 Appendix 66
7.1 Abbreviations 66
7.2 References 68
7.3 Methodology 76
7.4 Contact Us 76
7.5 Disclaimer 77

Get detailed TOC at:

http://www.reportsandintelligence.com/frontier-pharma-psoriasisidentifying-and-commercializing-first-in-class-innovationmarket/table-of-contents

Contact Us:
Deep Joshi
5933 NE Win Sivers Drive,
#205, Portland, OR 97220
United States
Direct: +1 (617) 674-4143
Toll Free: +1 (855) 711-1555
Fax: +1 (855) 550-5975
Email us: help@reportsandintelligence.com
Web: http://www.reportsandintelligence.com
Blog: http://www.reportsandintelligence.com/blog